Relistor

Orange BookUNIISPLATC A06AH01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSalix Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA06AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6564915006
1 BOTTLE in 1 CARTON (65649-150-06) / 6 TABLET in 1 BOTTLE
ndc11
6564915090
90 TABLET in 1 BOTTLE (65649-150-90)

Annotations

UNII (FDA Substance ID)

RFO6IL3D3M

METHYLNALTREXONE BROMIDE

RxCUI 979111

Orange Book

N208271

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RFO6IL3D3M",
    "rxcui": "979111",
    "inchikey": "IFGIYSGOEZJNBE-NQMNLMSRSA-N",
    "display_name": "METHYLNALTREXONE BROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c488fb7c-0a5b-487c-b452-996809d1cb99": {
      "match": "brand_token",
      "title": "RELISTOR (METHYLNALTREXONE BROMIDE) TABLET RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]",
      "spl_version": "68",
      "published_date": "2026-05-20"
    }
  },
  "productid": "65649-150_9db15b8c-2928-4b75-a33b-548416afc8c9",
  "productndc": "65649-150",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208271",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jul 19, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLNALTREXONE BROMIDE",
  "proprietary_name": "Relistor",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208271",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methylnaltrexone bromide",
  "start_marketing_date": "20080801",
  "active_numerator_strength": "150"
}

Related drugs

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